Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:

Insulin secretion

Secondary Outcome Measures:

Peripheral insulin sensitivity

Endothelial function

Pharmacokinetics

Estimated Enrollment:

16

Study Start Date:

April 2005

Primary Completion Date:

January 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Renal failure patients on dialysis which is planned to receive a renal transplant

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00139035